CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 25, 2017 Strukmyer Medical Pamela Liberto Director of OA 1801 Big Town Blvd Suite #100 Mesquite, Texas 75149 Re: K171645 Trade/Device Name: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle Regulatory Class: Unclassified Product Code: KGN Dated: June 2, 2017 Received: June 5, 2017 Dear Pamela Liberto: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171645 Device Name CoMatryx Collagen Wound Dressing ### Indications for Use (Describe) CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd degree burns, cuts, abrasions, and surgical wounds. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995, ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) SUMMARY #### I. ADMINISTRATIVE Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared. Strukmver Medical 1801 Big Town Blvd, Suite 100 Mesquite, Texas 75149 Telephone No.: 214-275-9595 Facsimile No.: 214-275-6748 Contact Person: Pamela Liberto E-Mail: pliberto@strukmyer.com July 20, 2017 Date Prepared: #### II. DEVICE NAME Proprietary Name: CoMatryx Collagen Wound Dressing Common or Usual Name: Collagen Wound Dressing Classification: Dressing, Wound, Collagen Regulatory Class: Unclassified Product Code: KGN #### III. PREDICATE DEVICE: CollaTek Powder K012990, Biocore Medical Technologies, Inc. (Now sold under the name Medifil II Particles by Human BioSciences, Inc., Gaithersburg, MD 20878). #### IV. DEVICE DESCRIPTION: Collagen Wound Dressing, a native bovine Type I Collagen which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound {4}------------------------------------------------ environment in the management of wound healing. The CoMatryx Collagen Wound Dressing is provided sterile in the following patient ready configurations: - 10 gram Bottle - 1 gram Vial ● - 1 gram pouch ● #### V. INTENDED USE CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd degree burns, cuts, abrasions, and surgical wounds. #### VI. COMPARISON TO PREDICATE DEVICE CoMatryx Collagen Wound Dressing is Type 1 bovine collagen which absorbs wound fluid, maintains a moist wound environment and is equivalent to predicate products currently in commercial distribution. Both Predicate and Strukmyer CoMatryx Collagen Wound dressings are derived from Type 1 bovine collagen. Infrared Spectroscopy (IR) Scan provided as attachment of predicate and Strukmyer Collagen Wound dressings match identically proving that material composition of both products are same. Both predicate and Strukmyer collagen dressings are ground to powder. This formulation does not affect the intended use or alter the fundamental scientific technology of the device. By comparing product characteristics such as physical shape, IR Spectrum, pH, color, absorbency and moisture content of both predicate and Strukmyer Collagen Wound dressings, it can be concluded that Strukmyer Collagen Wound dressings is substantially equivalent to the predicate device. The CoMatryx Collagen Wound Dressing is as safe and effective as the predicate devices referenced herein. CoMatryx Collagen Wound Dressing has similar intended uses, technological characteristics, and basic principles of operation as the aforementioned predicate device and raises no new issues of safety or effectiveness. CoMatryx Collagen Wound Dressing is substantially equivalent to the predicate device. See below for a comparison table. {5}------------------------------------------------ | Parameters | CoMatryx Collagen Wound<br>Dressing | CollaTek* Powder<br>(aka Medifil II Particles)<br>BioCore K012990 | Test Methods<br>(standards) | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Indications for<br>use | May be used in the<br>management of:<br>• Partial and full thickness<br>wounds<br>• Pressure (stage I-IV) and<br>venous ulcers<br>• Ulcers caused by mixed<br>vascular etiologies<br>• Venous stasis and<br>diabetic ulcers<br>• 1st and 2nd degree burns<br>• Cuts, abrasions, and<br>surgical wounds | May be used in the<br>management of:<br>• Partial and full thickness<br>wounds<br>• Pressure (stage I-IV) and<br>venous ulcers<br>• Ulcers caused by mixed<br>vascular etiologies<br>• Venous stasis and<br>diabetic ulcers<br>• 1st and 2nd degree burns<br>• Cuts, abrasions, and<br>surgical wounds | 510k Comparison | | Product Code | KGN | KGN | 510K | | Rx | Yes | Yes | 510K | | Physical Shape | Powder | Powder | 510K | | Color | White to off-white | White to off-white | Visual | | Single Use | Single use only | Single use only | 510K | | Package Sizes | 1 gram in vial<br>1 gram in pouch<br>10 grams in bottles | 1 gram in vial<br>1 gram in pouch<br>10 grams in bottles | 510K | | Water<br>Absorption<br>Capacity | NLT 20 times its weight in<br>USP Purified Water | NLT 20 times its weight in<br>USP Purified Water | Strukmyer Procedure<br>#HOMA-AFTP5R | | Particle Size | Powder | Powder | Strukmyer Procedure<br>#HOMA-AFTPRK | | Product Type | Collagen | Collagen | 510K | | Product<br>Description | Type I Bovine Collagen | Type I Bovine Collagen | 510K | | Animal Tissue | Dermis | Dermis | 510K | | Sterile | Yes | Yes | 510K | | Sterilization<br>Method | E-Beam | E-Beam | 510K | | Product<br>Classification | unclassified | unclassified | FDA | | Moisture content | ≤ 17% | ≤ 17% | Strukmyer Procedure<br>#HOMA-9YQRG8 | | pH | ≥ 2.5 | ≥ 2.5 | Strukmyer Procedure<br># HOMA-9Z9HUM | | InfraRed<br>Spectroscopy<br>Scan | Characteristic of Material,<br>comparable | Characteristic of Material,<br>comparable | Strukmyer Procedure<br># HOMA-A2CJEJ | | SDS-PAGE<br>Analysis | Characteristic of Material,<br>comparable | Characteristic of Material,<br>comparable | Alamo Labs, Inc.<br>Report#3480-01 | {6}------------------------------------------------ #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility Biocompatibility testing of CoMatryx Collagen Wound Dressing has been conducted in accordance with the testing standards of ISO 10993: "Biological Evaluation of Medical Devices." Biocompatibility testing included the following tests: - . Cytotoxicity - Sensitization Guinea Pig ● - . Intracutaneous Irritation Test - . Acute Systemic Toxicity # Animal Study Since the MEM Endpoint Dilution Test (in-vitro) indicated cytotoxic effect for CoMattyx Collagen Wound Dressing, a Wound Healing Study as requested by FDA was conducted to analyze the effect of CoMatryx Collagen on porcine wounds. The Wound Healing study shows no evidence of impairment of wound healing with the use of CoMatryx Collagen wound dressing. #### VIII. CONCLUSION Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results, we conclude that the CoMatryx Collagen Wound Dressing performs at least as well as the predicate device. The CoMatryx Collagen Wound Dressing is therefore considered to be substantially equivalent to the above-mentioned predicate device. # End of Summary